Starting from the first week of April, the Chinese government regulated that only those test kits which are approved by the CFDA can be exported. Export approvals of all those who were not yet in the CFDA list have been revoked.
There are only 5 manufacturers of IgG/IgM test kits manufacturers in the CFDA registration list. They got the approval in an expedited process in Jan and Feb right after the outbreak in Wuhan. The special and emergency approval process was terminated in March. Manufacturers who missed this window will spend one more year to get approved and admitted.
Sourcing Spectrum can source from two of the CFDA manufacturers.
- Whole Blood, Serum and Plasma Sample Types
- Result in 1-15min visually
- Independent IgM and IgG results
- Validated by Hundreds of Clinical Samples
- CFDA/NMPA approved, CE labeled
Sourcing Spectrum is a sourcing and supply chain consulting company based in Shenzhen.
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